LIVE WEBINAR:

Management Controls Under QSR and ISO 13485

Date: Thursday June 29 2017

Time: 1:00 PM ET | 10:00 AM PT

Duration: 90mins with Q&A


Webinar Description:

The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly stated that the management controls subsystem is the central subsystem because it is the "glue that holds the quality system together." Since it is individuals in top management that the FDA will typically seek to fine or prosecute in the event of major noncompliance, this session is key for those individuals who are members of top management, or those regulatory professionals who need to understand these requirements to assure top management is fulfilling its responsibilities. This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews.



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Jeff Kasoff, RAC, CMQ/OE


Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS in 1996, his Manager of Quality and Organizational Excellence certification from ASQ in 2013, and his Lean Black Belt from IIE in 2014.

Date: Thursday June 29, 2017
Time: 1:00 PM ET | 10:00 AM PT
Duration: 90mins with Q&A

Topics covered in this webinar:

  • QSR and ISO 13485 requirements for management controls
  • Organizational structure
  • Establishment of an internal audit program
  • Establishment of your company’s quality policy
  • Contents of your company’s quality plan
  • Best practices for conducting management reviews
Who Should Attend:

This webinar will provide valuable assistance to all regulated companies, since management controls is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • Executive management
  • Senior and mid-level management
  • Regulatory management
  • QA management
Single Registration
Single Attendee: $195.00 + HST CAD per session
Single attendee refers to single participant at a single computer/login.

Group Registration
Group of 5 or less per location: $400.00 + HST CAD per session
Group of 6 to 10 attendees per location: $750.00 + HST CAD per session
Group of 11 to 20 attendees per location: per location: $1250.00 + HST CAD per session
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.


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IPA is the premier Canadian provider of training and skill development seminars, conferences, and expositions for professionals engaged in pharmaceutical, biotechnology, medical device, natural health products, cosmetics, and Allied industries.

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